Merck is going to have to wait a little longer to see if its campaign to extend an approval for the cervical-cancer vaccine Gardasil to older women has succeeded with regulators. The pharma giant says that the FDA has extended its review period and Merck now expects a decision by the end of this year.
Currently approved to guard girls and women from 9 to 26, Merck has been pushing a request to bump the top age limit to 45 for the past two years. Last year Merck succeeded in gaining an approval to use Gardasil for boys and men 9 to 26 to prevent genital warts that cause cervical cancer. And Merck has been advocating an approval for older women based on data that the vaccine can prevent precancerous lesions spurred by HPV.
Merck was stiff armed by the agency early on, though, as regulators asked for long-term efficacy data on the vaccine. And Merck delivered, providing four-year data demonstrating an 88.7 percent efficacy rate versus 91 percent at the two-year mark.
Gardasil has been a blockbuster performer in the U.S., but it fell far short of full acceptance and now faces competition from Cervarix. Sales slid 20 percent last year to $1.1 billion. Merck could tap a larger market for the franchise, provided the FDA obliges it with an approval.
- here's the story from the Wall Street Journal